Trial Outcomes & Findings for Comparison of PIEB vs CEI for Labor Analgesia (NCT NCT02949271)
NCT ID: NCT02949271
Last Updated: 2019-01-11
Results Overview
The volume of local anesthetic that the patient received through activation of the patient-controlled epidural analgesia system per hour.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
179 participants
Primary outcome timeframe
duration of labor, up to 24hrs
Results posted on
2019-01-11
Participant Flow
The study took place at Duke University Medical Center from November 2016-November 2017.
298 were assessed for eligibility and 119 subjects were excluded due to not meeting exclusion criteria.
Participant milestones
| Measure |
Programmed Intermittent Epidural Bolus
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Overall Study
STARTED
|
90
|
89
|
|
Overall Study
COMPLETED
|
61
|
59
|
|
Overall Study
NOT COMPLETED
|
29
|
30
|
Reasons for withdrawal
| Measure |
Programmed Intermittent Epidural Bolus
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
5
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
6
|
|
Overall Study
Physician Decision
|
5
|
5
|
|
Overall Study
Protocol Violation
|
6
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Delivered prior to intervention
|
7
|
9
|
|
Overall Study
Outside the window for cervical dilation
|
2
|
3
|
Baseline Characteristics
Comparison of PIEB vs CEI for Labor Analgesia
Baseline characteristics by cohort
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
29.8 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
29.2 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
61 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: duration of labor, up to 24hrsThe volume of local anesthetic that the patient received through activation of the patient-controlled epidural analgesia system per hour.
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Volume of Local Anesthetic Received Through Patient Controlled Epidural Analgesia (PCEA) Per Hour
|
4.03 milliliters per hour
Interval 2.15 to 7.07
|
4.52 milliliters per hour
Interval 2.99 to 8.63
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsThe total volume of local anesthetic that the patient received from the CAPP pump per hour.
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Volume of Local Anesthetic Required Per Hour
|
11.49 milliliters per hour
Interval 9.21 to 14.84
|
12.38 milliliters per hour
Interval 10.45 to 17.03
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsPopulation: Data not collected since it required extracting data that are not collected as part of standard practice and study team was not available sometimes when the patient delivered and this data had to be collected then before the pump was used for another patient.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsMeasured using a verbal analog pain scale of 1-10, where 0=no pain and 10=worst possible pain.
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Maximum Reported Labor Pain Score
|
3 score on a scale
Interval 0.0 to 6.0
|
2 score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsPopulation: Data not collected on 10 participants in the Programmed Intermittent Epidural Bolus group and in 7 in the continuous epidural infusion group.
The Modified Bromage Score ranges from 1-5. 1 = complete block, 2 = almost complete block, 3 = partial block, 4 = detectable weakness of hip flexion, and 5 = no detectable weakness of hip flexion while supine.
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=51 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=52 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score
Score of 5
|
37 Participants
|
26 Participants
|
|
Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score
Score of 4
|
9 Participants
|
20 Participants
|
|
Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score
Score of 3
|
4 Participants
|
3 Participants
|
|
Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score
Score of 2
|
1 Participants
|
2 Participants
|
|
Degree of Motor Blockade Measured as Lowest Recorded Modified Bromage Score
Score of 1
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsModes of delivery: spontaneous vaginal delivery (SVD), assisted vaginal delivery (AVD), and caesarean delivery (CD)
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Total Number of Subjects Experiencing Each Mode of Delivery
SVD
|
41 Participants
|
37 Participants
|
|
Total Number of Subjects Experiencing Each Mode of Delivery
AVD
|
5 Participants
|
5 Participants
|
|
Total Number of Subjects Experiencing Each Mode of Delivery
CD
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsDetermined by the number of times subject activates the PCEA pump
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Number of Patient Controlled Epidural Analgesia (PCEA) Attempts
|
0.75 attempts
Interval 0.33 to 1.84
|
0.63 attempts
Interval 0.42 to 1.35
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsRatio generated by the number of times subjects activates PCEA and receives additional anesthetic compared with times subject activates PCEA and does not receive additional anesthetic.
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Ratio of Patient Controlled Epidural Analgesia (PCEA) Successful Attempts to Unsuccessful Attempts
|
0.17 ratio of attempts
Interval 0.1 to 0.3
|
0.12 ratio of attempts
Interval 0.08 to 0.18
|
SECONDARY outcome
Timeframe: duration of labor, up to 24 hrsNumber of patients who needed a vasopressor medication to treat a drop in blood pressure
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Number of Subjects Experiencing Hypotension Requiring Vasopressor Treatment
|
8 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsOutcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Duration of Second Stage of Labor
|
44 minutes
Interval 15.0 to 119.0
|
63 minutes
Interval 27.0 to 130.0
|
SECONDARY outcome
Timeframe: duration of labor, up to 24hrsDetermined using a 5-point scale where 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, 5=very satisfied. Subjects were considered "satisfied" if selected "very satisfied" or "satisfied" on the patient questionnaire.
Outcome measures
| Measure |
Programmed Intermittent Epidural Bolus
n=61 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 Participants
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Number of Subjects Who Were Satisfied With Procedure
Very satisfied
|
35 Participants
|
39 Participants
|
|
Number of Subjects Who Were Satisfied With Procedure
Satisfied
|
9 Participants
|
3 Participants
|
Adverse Events
Programmed Intermittent Epidural Bolus
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Continuous Epidural Infusion
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Programmed Intermittent Epidural Bolus
n=61 participants at risk
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive either 6 mL every 45 minutes in the PIEB arm (first bolus 30 minutes after epidural initiation). All study participants will be provided with PCEA set to 8mL boluses with a 10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Programmed Intermittent Epidural Bolus
Ropivacaine
Fentanyl
|
Continuous Epidural Infusion
n=59 participants at risk
Epidural catheters will be placed at the L3/4 or L4/5 interspace with 4 cm of catheter being left in the epidural space. Epidural analgesia will be initiated and maintained with a solution of ropivacaine 0.1% with fentanyl 2 mcg/ml. After the initial epidural loading dose of 20 mL is administered in incremental fashion, patients will receive 8mL/hr of continuous infusion beginning immediately after the loading dose for the maintenance of analgesia in the CEI arm. All study participants will be provided with PCEA set to 8mL boluses with a10-minute lockout period. The maximum amount of PCEA analgesia will be set to a 1-hour maximum of 45mL.
Continuous Epidural Infusion
Ropivacaine
Fentanyl
|
|---|---|---|
|
Cardiac disorders
Hypotension
|
13.1%
8/61 • Duration of labor, up to 24hrs
|
5.1%
3/59 • Duration of labor, up to 24hrs
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place